Medical Writer

vor 6 Monaten

Home Office, Schweiz MoonLake Immunotherapeutics Vollzeit

**Your mission**:
As a (Senior) Medical Writer, you are an integral part of MoonLake’s Clinical Development team responsible for providing medical writing support to our clinical development programs including preparation, development, review, revision and finalization of clinical, medical and regulatory documents for submission to external stakeholders and communities.

**Your profile**:
**MAJOR ACCOUNTABILITIES**:

- Prepare, edit and review medical, regulatory and clinical documents to support MoonLake’s development programmes including clinical study protocols, investigator brochures, non-clinical summaries, briefing documents, safety/efficacy summaries and clinical study reports.
- Drive and coordinate the development of cross-functional documents to ensure completion to timelines.
- Support cross functional project teams by providing medical writing consultancy on various aspects and provide advice on Medical Writing issues and help to resolve problems
- Research and develop clinical and medical materials, ensuring that outputs are appropriately referenced and accurate in content and editorial style.
- Develop and support QC processes to ensure quality and accuracy within and between development documents.
- Assist in the development of templates for core documents that ensure the compliance and consistency
- Work with key functions to develop MoonLake’s in-house style to create a consistent and high quality image across MoonLake documents.

**JOB REQUIREMENTS**:
**Education**:

- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.

**Experience**:

- At least 5 years’ experience of medical writing in the field of Clinical Development within the pharmaceutical industry or contract research organisations
- Experience in writing for clinical trials across a range of therapeutic areas and geographies, ideally with immunology/dermatology experience
- Previous experience in medical communications, editing and/or publishing would be advantageous

**Skills/Knowledge/Behavioural Competencies**:

- Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.
- Knowledge of ICH guidelines and data protection law applicable to medical writing.
- Excellent attention to detail
- Team player able to work in a flexible, collaborative style with colleagues and teams within the company and with external advisors including CROs and consultants.
- Good time-management skills, resourcefulness, adaptability, flexibility and an ability to manage simultaneous priorities and adapt to changing timelines.
- An ability to work in a structured, independent manner within dynamic teams and a constructive, service‐oriented approach to challenging situations.
- Excellent command of the English language, both verbal and written communication skills
- Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).Demonstrate keen attention to detail and faultless grammar and spelling

  • Principal Medical Writer

    vor 6 Monaten

    Home Office, Schweiz ICON Vollzeit

    As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be doing**: - Develop regulatory documents for submission to regulatory agencies globally, including **Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and...

  • Medical Writer and Peer Reviewer Pool

    vor 6 Monaten

    Home Office, Schweiz H+O communications Ltd. Vollzeit

    Wir sind eine Full-Service-Agentur für medizinische Kommunikation und ein Verlagshaus in Zürich und erweitern unseren Pool an erfahrenen, freiberuflichen Medical Writern und Peer Reviewern für unsere Journale - Verfassen und Entwickeln von Kongress-Highlights, E-Learning-Modulen, medizinischen Berichten und Peer-Review-Publikationen in einer Vielzahl von...

  • Sponsor Dedicated Principal Medical Writer

    vor 3 Monaten

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **Principal Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient...

  • Sponsor Dedicated Principal Medical Writer

    vor 6 Monaten

    Home Office, Schweiz Syneos Health Clinical Vollzeit

    Description Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we...

  • Single Sponsor Principal/sr Medical Writer

    Vor 7 Tagen

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Single Sponsor Principal/sr Medical Writer

    Vor 7 Tagen

    Home Office, Schweiz Syneos Health Commercial Solutions Vollzeit

    **Description** **Senior Medical Writer** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Associate Director, Coba Operations and System

    vor 7 Monaten

    Home Office, Schweiz BeiGene Vollzeit

    General Description: The Associate Director, COBA Operations and System Support (Global Medical Affairs) will serve as the point of contact for the technical operational needs of the Medical Affairs teams across Europe and support systems, tools, and other operational initiatives. The incumbent will work with the Field Medical teams globally in support of...

  • Sponsor Dedicated Sr Clinical Editor

    vor 3 Monaten

    Home Office, Schweiz Syneos - Clinical and Corporate - Prod Vollzeit

    **Description** **Senior Medical Editor** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...

  • Manager, Brand Development

    vor 4 Monaten

    Home Office, Schweiz Brand Institute Inc Vollzeit

    **Manager, Brand Development - Basel** Brand Institute is proud to have named over 75% of 2019 drug name approvals worldwide. Thanks to our loyal customer base, Brand Institute has been #1 in drug name approvals for 18 consecutive years. Our unique, category-leading brand name and identity services include Name Development (i.e., USAN/INN, Brand, Clinical...

  • Market Access Director

    vor 6 Monaten

    Home Office, Schweiz Dexcom Vollzeit

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...

  • Sr Lead Market Access Account Executive

    vor 6 Monaten

    Home Office, Schweiz Dexcom Vollzeit

    About Dexcom Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and...

  • Global Clinical Compliance Lead

    vor 3 Monaten

    Home Office, Schweiz BeiGene Vollzeit

    General Description: - The Global Clinical Compliance Lead (gCCL) is responsible for implementing the global clinical compliance and inspection management strategy across BeiGene clinical programs at study level, as assigned. The gCCL provides compliance and quality support to BeiGene GCO study teams for the assigned programs / studies and ensures that...

  • Content Marketing Lead

    vor 6 Monaten

    Home Office, Schweiz SOPHiA GENETICS Vollzeit

    Do you love working in a fast-paced environment? Want to work in an environment that will continuously challenge you to do more, try more, and learn more in a cross-functionally position? Bring your knowledge & passion for healthcare to **SOPHiA GENETICS** as our new **Content Marketing Lead **for **Rolle in Switzerland (remote to be discuss).** **Why...